Sensor dispenser device and method of use

ABSTRACT

Disclosed herein are electrochemical sensor dispensing methods and apparatus. The sensors dispensers can include an elongate body having a proximal end and a distal, the elongate body including a proximally positioned dispensing surface with an opening for dispensing a sensor. A storage chamber having a series of connected sensors is positioned distally and can feed a proximally positioned sensor feeder mechanism. The feeder mechanism includes an elongate member having a first end and second end, the second end adapted to pivot between a sensor engaging position and a sensor feeding position.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.11/138,079, filed May 25, 2005, entitled “SENSOR DISPENSER DEVICE ANDMETHOD OF USE”, which is hereby incorporated by reference herein in itsentirety.

BACKGROUND OF THE INVENTION

Analyte detection in physiological fluids, e.g. blood or blood-derivedproducts, is of ever increasing importance to today's society. Analytedetection assays find use in a variety of applications, includingclinical laboratory testing, home testing, etc., where the results ofsuch testing play a prominent role in diagnosis and management in avariety of disease conditions. Analytes of interest include glucose fordiabetes management, cholesterol, and the like. In response to thisgrowing importance of analyte detection, a variety of analyte detectionprotocols and devices for both clinical and home use have beendeveloped.

One type of system that allows people to conveniently monitor theirblood glucose levels includes a sensor (e.g., a disposable test strip),for receive a blood sample for a user, and a meter that “reads” the teststrip to determine the glucose level in the blood sample. The test striptypically includes an electrical contact area at one end for mating withthe meter and a sample chamber at the other end that contains reagents(e.g., glucose oxidase and a mediator) and electrodes. To begin thetest, the test strip is inserted into the meter and the user applies ablood sample to the sample chamber. The meter then applies a voltage tothe electrodes to cause a redox reaction and the meter measures theresulting current and calculates the glucose level based on the current.After the test, the test strip can be disposed.

It should be emphasized that frequent measurements of blood glucoselevels may be critical to the long-term health of many users. As aresult, there is a need for blood glucose measuring systems that areeasy to use. One improvement in blood glucose monitoring has been areduction in the volume of sample needed to perform a test, whichreduces the trauma associated acquiring blood samples. However, assample sizes become smaller, the dimensions of the sample chamber andelectrodes in the test strip also become smaller. This, in turn, maymake test strips become more difficult to handle.

One solution has been the use of cassettes that hold a series of teststrips (e.g., a dozen) that can be mechanically fed from the cassetteinto a meter without handling by a user. For example, one such cassettehas a circular configuration with axially positioned test strips,through a complicated mechanized procedure, individual test strips arerotated into position and fed into the meter. Unfortunately, suchsystems can require complex mechanical structures that result in addedexpense and unwanted bulk.

Accordingly, there is a need to for blood glucose measuring systems withfeatures for measuring blood glucose levels conveniently and reliably.

SUMMARY OF THE INVENTION

The present invention generally provides methods and apparatus forelectrochemically determining an analyte concentration in aphysiological sample. In one aspect, described herein, anelectrochemical sensor dispenser device is disclosed. The devicecomprises an elongate body having a proximal and a distal end, with aproximally positioned dispensing surface having an opening fordispensing a sensor. The elongate body houses a storage chamber thatstores a series of electrochemical sensors and sensor feeder mechanismthat can dispense the sensors to a meter.

In one embodiment, the feeder mechanism includes an elongate engagingmember having a first end and second end, the second end adapted to movebetween a sensor engaging position and a sensor feeding position. Forexample, the elongate member can be pivotally secured at the first endto the elongate body of the sensor dispenser. Alternatively, theelongate member is fixedly secured at the first end and is flexible. Todispense a sensor, the feeder mechanism is shifted from the sensorengaging position to the sensor feeding position.

In one aspect, the sensor dispenser is adapted for use with a meter suchthat engaging the dispenser with a meter causes the elongate member tomove from the sensor dispensing position to the sensor feeding position.In the sensor feeding position, the meter can remove a sensor from thedispenser.

To facilitate sensor dispensing, the sensor dispenser and/or meter caninclude alignment features. These features assist a user with orientingthe dispenser and meter, and can also help to align the sensor feedingmechanism with a sensor mating mechanism on the meter. In one aspect,the sensor dispenser includes a portion that extends beyond the sensorfeeding mechanism to provide an alignment surface. The alignment surfacecan contact a complementary surface on the meter. A guide blade on thedispenser can also facilitate alignment. For example, a guide bladeextending from a proximal surface of the dispenser can be received in arecess within the meter.

The sensors used with the sensor dispenser can be connected to oneanother via a flexible connection. In the storage chamber, the flexibleconnection allows the sensors to be configured in a space-saving foldedcondition and then be pivoted into position for dispensing. To protectthe sensors, the elongate body can provide a generally airtightenclosure. When a user wishes to dispense a sensor, a resealable openingat the proximal end of the elongate body can be opened.

In one aspect, the sensors are electrochemical sensors having alongitudinally extending reaction chamber defined by opposed electrodes.Laterally spaced electrical contact areas positioned on the surface ofthe sensor can mate with the meter to allow the meter to electricallycommunicate with the electrodes. The sensors can also have matingfeatures for engaging with the feeding mechanism of the sensor dispenserand/or with the sensor mating mechanism of the meter. In one aspect, themating feature is an open area in which the elongate member can sit whenpositioned in the sensor engaging position.

In another embodiment, a system for delivering an electrochemical sensorto a meter is disclosed, including a sensor dispenser having a sensorstorage area and a sensor dispensing mechanism. The sensor dispensermechanism includes an elongate member that can move between a sensingdispensing position and a sensor engaging position. The system furtherincludes a meter adapted to receive a sensor, the meter including asurface adapted to engage the sensor dispensing mechanism and move theelongate member from a sensor dispensing position to a sensor engagingposition.

Methods of using the sensor dispenser are also disclosed herein. In oneaspect, an array of connected sensors is positioned within a sensordispenser having a feeding mechanism that holds a first sensor in place.Insertion of a meter into the dispenser actives the feeder mechanism.For example, contacting the feeder mechanism with the meter releases thesensor from the feeder mechanism, while a mating mechanism on the meterengages the sensor. As the sensor is released from the dispenser, themating mechanism locks the sensor within the meter. Separating the meterfrom the dispenser can tear the sensor away from the array of connectedsensors and can pull the next sensor into engagement with the feedermechanism.

Once the sensor is mated with the meter, a user can deliver a sample ofphysiological fluid to the sensor and perform an analysis. In oneaspect, the sensor and the meter are used to determine the concentrationof glucose in whole blood. The user delivers a sample (e.g., a wholeblood sample) into a reaction chamber within the sensor, the reactionchamber having a reagent and electrodes. The meter creates an electricalpotential across the electrodes and collects data (e.g., time andcurrent data). Based on the collected data the meter can provide theuser with information about an analyte within the sample (e.g., glucoseconcentration). After completion of a test, the sensor can be ejectedfrom the meter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of the sensor dispenserdisclosed herein;

FIG. 2A is a perspective view of another embodiment of the sensordispenser including a resealable opening;

FIG. 2B is a perspective view of the sensor dispenser of FIG. 2A open atone end;

FIG. 3 is a perspective view of an exemplary sensor for use with thesensor dispenser;

FIG. 4 illustrates an array of the sensors of FIG. 3 connective viaflexible hinges;

FIG. 5 is an exploded view of the sensor dispenser disclosed herein;

FIG. 6 is a partial perspective view of the dispensing end of the sensordispenser;

FIG. 7 illustrates the sensor dispenser of FIG. 6 in a dispensingconfiguration;

FIG. 8A is a cut-away view of the sensor dispenser partially engaged bya meter;

FIG. 8B is a cut-away view of the sensor dispenser of FIG. 8A with thesensor dispenser and meter fully engaged;

FIG. 9 is another view of the sensor dispenser and meter in a partiallyengaged configuration;

FIG. 10 is a perspective view of one embodiment of the meter disclosedherein and adapted for use with the sensor dispenser disclosed herein;

FIG. 11A is a perspective view of the sensor dispenser and meter;

FIG. 11B is a perspective view of the meter inserted into the sensordispenser;

FIG. 11C is a perspective view of the sensor dispenser and the meterwith a dispensed sensor;

FIG. 11D is a perspective view of the meter disclosed herein including asensor positioned therein;

FIG. 12A is a perspective view of the meter with a sensor lockedtherein; and

FIG. 12B is a perspective view of the sensor and meter of FIG. 12A withthe sensor being ejected from the meter.

DETAILED DESCRIPTION

Disclosed herein, are sensor dispensing methods and devices suited forthe storage and/or delivery of a wide variety of electrochemicalsensors, such as, sensors suited for use in the determination ofanalytes in whole blood or derivatives thereof. In one aspect, thesensor dispenser can store an array of such sensors and can dispenseindividual sensors for receipt by a meter. Also disclosed herein aresensor dispensing systems that include a meter adapted to mate with thesensor dispenser and to receive sensors therefrom. In one aspect, whenthe meter engages the sensor dispenser, a feeding mechanism on thesensor dispenser is activated and a sensor is dispensed.

In one embodiment, the dispenser described herein includes an elongatebody containing a distal sensor storage chamber, adapted to hold atleast one electrochemical sensor (e.g., an array of connected sensors),and a proximal sensor feeder mechanism adapted to deliver a sensor to ameter. One exemplary embodiment of sensor dispenser 10 adapted todispense an array of sensors is illustrated in FIG. 1, and includes anelongate body 12 having a proximal end 14 and a distal end 16. Thedistal portion of elongate body 12 can include a storage area 18 forholding an array of connected sensors 20. In particular, a series offolded sensors can be positioned with a cavity 22 and then individualdispensed from a proximally positioned feeder mechanism 24. While thesensor storage area is described as “distal” herein and the feedermechanism is described as “proximal,” these terms are used forconvenience. On skilled in the art will appreciate that the location ofthe feeder mechanism will depend on the orientation of the sensordispenser and could be positioned in any location adjacent to thestorage chamber which would allow dispensing of the sensors (e.g., ontop of, distally to, etc.).

Body 12 can have a variety of shapes including, for example, a generallycylindrical shape as shown in the FIGS. One skilled in the art willappreciate a variety of alternative shapes capable of defining storagearea 18 and feeder mechanism 24 could be used. Body 12 can includefeatures to protect sensors positioned within sensor dispenser 10. Forexample, body 12 can enclose storage area 18 and feeder mechanism 24 ina protective shell, as shown in FIGS. 2A and 2B, to shield sensors 20positioned therein from the environment. For example, body 12 can definea resealable chamber that limits exposure of sensors 20 to theatmosphere. When a user wishes to dispense a sensor, body 12 is openedvia a resealable flap 28 to expose a proximally positioned dispensingsurface 23. After dispensing a sensor, body 12 is closed to provide agenerally airtight container. One skilled in the art will appreciatethat dispenser 10 can include openings that have a variety ofconfigurations and which provide alternative mechanisms for accessingfeeder mechanisms 24, including, for example, threaded openings, snapfit openings, frictional fit openings, tongue and groove opening, andcombinations thereof.

Body 12 can, in one embodiment, be formed as a single piece with cavity22 and feeding mechanism 24 formed integrally. After dispensing all thesensors from cavity 22, sensor dispenser 10 could be disposed.Alternatively, sensor dispenser 10 is refillable and includes adetachable storage area 18. When all the sensors in cavity 22 aredispensed, storage area 18 could be detached from the device and a newstorage area 18 (containing sensors) could be attached to sensordispenser 10 to refill the sensor dispenser. One skilled in the art willappreciate that storage area 18 can be mated with sensor dispenser 10 ina variety of ways, such as, for example, with a snap fit, threads, slotand grove, or a combination thereof.

In one aspect, elongate body 12 can include a window 30 that allows auser to visually estimate the number of sensors remaining in cavity 22.A visual inspection will allow a user to determine when the supply ofsensors runs low. One skilled in the art will appreciate thatalternatively, or in addition, a variety of counting mechanisms,including electrical and mechanical based counters, could be used toalert a user to the quantity of sensors remaining within cavity 22.

The interior of storage area 18 can have a shape adapted for the storageand delivery of sensors 20. For example, interior of cavity 22 can beshaped to hold a folded array of sensors like those illustrated in FIGS.3 and 4. As shown, an array of sensors 20 a, 20 b, 20 c, 20 d, etc., areconnected via flexible hinges 32. Sensors 20 can be folded at hinges 32for storage in a folded stack and then unfolded for dispensing. At leasta portion of storage area 18 can have a shape corresponding to thefolded sensors. In addition, the interior walls of cavity 22 can includeguide features 21 to assist with moving sensors 20 from cavity 22 tofeeder mechanism 24. In one embodiment, storage area 18 includes guidefeatures 21 to hold and/or directed sensors 20 prior to delivery tofeeder mechanism 24. FIG. 5 illustrates guide features 21 defined byfirst and second protrusions that extend from the interior walls ofstorage area 18 and serve to contain the folded stack of sensors. As thesensors 20 are pulled during dispensing, the first sensor in the stackof folded sensors is pulled past the protrusions. In one aspect,protrusions are sized such that the sensors 20 slightly flex (i.e.,bend) as they are pulled past the protrusions. The guide features 21 canthus keep the folded stack of sensors orderly and can provide an openarea between the folded stack of sensors and feeder mechanism 24. Thisopen area allows sensors to move into position for receipt by feedingmechanism 24 and helps to prevent jamming.

Feeding mechanism 24 can engage the first sensor in the array of sensorsand can hold the sensor in position until a meter activates the feedingmechanism and allows the sensor to be dispensed. In one embodiment,feeding mechanism 24 hold a sensor in position by preventing proximalmovement of the sensor. FIG. 5 illustrates an exploded view of sensordispenser 10 including feeder mechanism 24 with a sensor engaging member40 that can move between a sensor engaging position and a sensordispensing position. When a meter engages dispenser 10, the sensorengaging member 40 is forced, by the meter, from the sensor engagingposition to the sensor dispensing position. In the sensor dispensingposition, the sensor is released by feeder mechanism 24 and can bedispensed.

Sensor engaging member 40 can include an elongate body 42 with a firstend 44 mated with body 12 and a second end 46 configured for mating withsensor 20. For example, second end 46 of sensor engaging member 40 canhave a shape adapted to mate with a portion of sensor 12. One skilled inthe art will appreciate that the configuration of the second end 46 ofsensor engaging member 40 can depend on the features of the sensor andcan be configured to hold a variety of differently shaped sensors.

Where a series of connected sensors are positioned within dispenser 10,the first sensor in the series can be prevented from dispensing bysensor engaging member 40. FIG. 6 shows sensor engaging member 40 in asensor engaging position with second end 46 of engaging member 40 matedwith sensor 20. In this position, sensor 20 cannot be dispensed.However, when a meter engages the proximal end of dispenser 10, themeter moves the sensor engaging member 40 into a sensor dispensingposition. FIG. 7 illustrates sensor engaging member 40 in a dispensingposition.

FIGS. 8A and 8B, illustrate a cut-away view of sensor dispenser 10engaged with a meter 49. As meter 49 engages the proximal end of sensordispenser 10 (feeder mechanism 24), the sensor engaging member 40 islifted from the sensor engaging position by the force of meter 49 (FIG.8B). Meter 49 can then mate with sensor 20.

Sensor engaging member 40, in one aspect, can be pivotally fixed todispenser 10, such that the sensor engaging member can pivot between asensor engaging position and a sensor dispensing position. In oneembodiment (as shown in FIG. 5), a pivot pin 52 can pivotally fixengaging member 40 to body 12. One skilled in the art will appreciatethat sensor engaging member 40 can be mated with body 12 in a variety ofalternative ways that allow the sensor engaging member to move between asensor engaging and a sensor dispensing position. In another exemplaryembodiment, sensor engaging member 40 is fixedly mated to body 12 and isflexible. When a meter engages feeder mechanism 24, the meter bendssensor engagement member 40 and moves it from a sensor engaging positionto a sensor dispensing position.

In one embodiment, engaging member 40 is biased in the sensor engagingposition. The meter can move the sensor engaging member from a sensorengaging position to a sensor dispensing position, and then after themeter is removed, the engaging member returns to the sensor engagingposition. For example, a spring can be positioned between body 12 andengaging member 40 to apply downward pressure. The spring allows theengaging member to travel upwards when contacted by the meter. When themeter is removed the action of the spring returns the engaging member tothe sensor engaging position. In an alternative aspect the engagingmember is resilient. For example, the engaging member can be fixedlymated with body 12 in the sensor engaging position. When the metercontacts the engaging member, the engaging member is bent upwards toallow for dispensing. When the meter is removed the resilient engagingmember returns to its original position. Other exemplary means forbiasing the engaging member include, for example, magnets andelectromechanical actuators.

Dispenser 10 can include other feature to assist with dispensing sensor20. In one aspect, the proximal surface of dispenser 10 includes stops56 which prevent sensor 20 from retreating into the dispenser. Stops 56allow sensor 20 to move in a proximal (dispensing) direction but limit(or prevent) distal movement. As the sensor travels into position infeeding mechanism 24, stops 56 contact the sides of sensor 20. In oneembodiment, as shown in FIG. 7, stops 56 can have a taper thatcorresponds to a “V” shape of the sensor. When the sensor moves past thestops, the stops contact the sides of the sensor and prevent distalmovement. One skilled in the art will appreciate that that configurationof the stops can be adapted to the shape of the sensor.

In one aspect, stops 56 cooperate with engaging member 40. When a sensoris engaged within feeder mechanism 24, stops 56 prevent distal movementwhile engaging member 40 prevents proximal movement. Together stops 56and engaging member 40 can control the movement of sensor 20.Alternatively, engaging member 40 mates with sensor 20 such that itprevents both proximal and distal movement.

The sensor dispenser can include other features that work with feedermechanism 24 to assist with dispensing sensors 20. For example,proximally positioned top and bottom interior surfaces 25 and 27 of body12, respectively, can assist with directing the sensors into engagementwith engaging mechanism 40. As shown in FIG. 5, surfaces 25 and 27 aregenerally flat and spaced apart a distance less than the height ofstorage chamber 18. As the connected sensors are pulled from the storagechamber, they encounter surfaces 25 and 27 and are directed into contactwith the engagement mechanism. In one aspect, surface 25 and/or 27 aresloped to help direct sensor 20. For example, top surface 25 can slopedownward and/or top surface 27 can slope upward to funnel sensors 20into feeding mechanism 24.

In addition, top interior surface 25 can include a recess or opening 50into which sensor engaging mechanism 40 can travel when the sensorengaging mechanism is in a sensor dispensing position (FIG. 1). Recess50 allows the sensor dispensing mechanism to move out of the way of asensor during the dispensing procedure. A second recessed 51 area can bepositioned in the bottom interior surface 27 for receiving at leastportion of engaging mechanism 40. The engaging member can be seatedwithin recess 51 while in the sensor engaging position.

Dispenser 10, as described herein, can include alignment features thatfacilitate alignment of feeder mechanism 24 of dispenser 10 with meter49. In particular, the alignment features can help bring meter 49 intocontact with feeder mechanism 24 to activate the feeder mechanism. Inaddition, alignment features can help to orient and align a sensormating mechanism 58 on meter 49 so that the sensor mating mechanism canreceive a sensor dispensed from sensor dispenser 10. Exemplary alignmentfeatures can include, markers (colors, arrows, etc.) that indicate theorientation of the dispenser and/or surface contours that help guidemeter 49 into contact with feeder mechanism 24.

In one aspect, the proximal surface of dispenser 10 can be shaped tomatch a corresponding shape on meter 49. FIG. 9 illustrates the proximalsurface of sensor dispenser 10 including an extension portion 60 thatextends proximally and corresponds to an upper surface 62 on meter 49.In use, upper surface 62 of meter 49 slides under extension portion 60and guides meter 49 into contact with feeder mechanism 24. In anotheraspect, sensor dispenser 10 includes a guide blade 64 that can mate witha recess 66 in meter 49 when the dispenser and meter are properlyaligned. The proximal surface of guide blade 64 can be tapered tofacilitate insertion of the guide blade into a recess within meter 49.In use, these alignment features will prevent sensor dispenser 10 andmeter 49 from mating unless the feeder mechanism 24 and sensor matingmechanism 58 are properly aligned for dispensing a sensor. One skilledin the art will appreciate that sensor dispenser 10 and meter 49 caninclude a variety of features to assist with alignment.

In one embodiment described herein an electrochemical meter adapted foruse with an electrochemical sensor is disclosed. The meter includes anarea to receive a sensor to perform an electrochemical analysisincluding a mating mechanism 58 for mating with sensors dispensed fromsensor dispenser 10. The mating mechanism is designed to hold and/orlock a sensor in position during analysis. For example, meter 49 caninclude a retention post 74 having a shape corresponding to at least aportion of sensor 20. When meter 49 is brought into contact with sensor20, positioned in feeder mechanism 24, the sensor can be directed intoan opening 72 and retention post 74 can mate with sensor 20. In oneembodiment, meter 49 can mate with sensor 20 at the same time thatdispenser 10 is mated with sensor 20. For example, retention post 74 canmate with a proximal portion of sensor 20 while feeder mechanism 24mates with a distal portion of sensor 20. Bringing meter 49 fully intocontact with feeder mechanism 24 then releases sensor 20 from feedermechanism 24 while sensor 20 remains locked within meter 49. FIG. 11shows sensor 20 positioned within meter 49 and retention post 74 lockingsensor 20 in place.

Meter 49 disclosed herein is also adapted to work with feeder mechanism24. In one aspect, the distal surface of meter 49 includes a locatingsurface 70 for contacting feeder mechanism 24. As shown in FIG. 10,surface 70 is tapered and recessed so that as meter 49 is brought intocontact with sensor dispenser 10, mating mechanism 58 contact sensor 20prior to feeder mechanism 24 releasing the sensor. As meter 49 movesfurther into engagement, surface 70 will then contact engaging member 40and move the engaging member into a sensor dispensing configuration.Depending on the positioning of the engaging member 40 and theconfiguration of surface 70, the mating mechanism can mate with sensor20 either prior to, at the same time as, or after sensor dispenserreleases sensor 10. In one embodiment, meter 49 and sensor dispenser 10are configured such that feeder mechanism 24 and mating mechanism 58mate with sensor 20 at the same time.

Distal surface 67 of meter 49 can include features that assist withdirecting sensor 20 into mating mechanism 58. For example, distalsurface 67 of meter 49 can be tapered around opening 72 to help guidesensor 20 into sensor mating mechanism 58. FIG. 10 shows tapered lead-insurfaces on the distal surface of meter 49 that help seat sensor 20within sensor mating mechanism 58.

The proximal portion of meter 49 can include a power source that canelectrically communicate with sensor 20 and a processor for directinganalysis, collecting data, and/or calculating a characteristic of ananalyte (e.g., analyte concentration). In addition, meter 49 can includea screen for interfacing with a user. One skilled in the art willappreciate that meter 49 can be adapted for analyzing substances using avariety of circuit configurations, user interfaces, and calculationschemes. Exemplary, meter configuration are disclose for example in U.S.Pat. No. 6,475,372 to Ohara et al., and U.S. Pat. No. 5,942,102 toHodges, et al., which are hereby incorporated by reference in theirentirety.

In another embodiment disclosed herein, a method of using sensordispenser 10 to dispense sensor 20 is disclosed. In one aspect, themethod includes using meter 49 to activate sensor dispenser 24 anddispensing a sensor 20 from sensor dispenser 10 to meter 49. FIGS. 11Athrough 11D illustrate the operation of sensor dispenser 10 in feeding asensor 20 to a meter 49.

Prior to delivery of a sensor, a user can first prepare dispenser 10 foroperation by opening access to sensor feeding mechanism 24. For example,body 12 can include a resealable access port at a proximal end 14, suchas an air tight cap (FIGS. 2A and 2B). Opening the proximal end ofdispenser 10 provides access to the proximal surface of sensor feedingmechanism 24.

A user can then align dispenser 10 with meter 49 and bring sensorfeeding mechanism 24 into contact with sensor mating mechanism 58, fordelivery of an individual sensor from sensor dispensing 10 to meter 49.FIG. 11A shows sensor dispenser 10 and meter 49 properly oriented andready to engage one another. As dispenser 10 and meter 49 are broughttogether the alignment features discussed above can assist with finetuning the alignment of feeder mechanism 24 and mating mechanism 58.FIG. 11B illustrates meter 49 engaged with sensor dispenser 10.

In one aspect, an array of connected sensors are positioned withindispenser 10, with feeding mechanism 24 holding or locking a firstsensor in place until the insertion of meter 49 into dispenser 10actives feeder mechanism 24. In one aspect, feeding mechanism 24 preventproximal movement, while stops 56 contact sensor 20 and prevent thesensor from moving distally. The sensor is also constrained by upper andlower surfaces 25, 27. Contacting feeder mechanism 24 with meter 49releases sensor 20 from feeder mechanism 24, while the mating mechanism58 of meter 49 engages the sensor. As sensor 20 is released fromdispenser 10, mating mechanism 58 locks the sensor within meter 49.Separating meter 49 from dispenser 10 can tear the sensor away from thearray of connected sensors and can pull the next sensor into engagementwith feeder mechanism 24. FIG. 11C illustrates meter 49 with a dispensedsensor 20 locked in mating mechanism 58.

Once sensor 20 is mated with meter 49, a user can deliver a sample ofphysiological fluid to the sensor and perform an analysis. In oneaspect, sensor 20 and meter 49 are used to determine the concentrationof glucose in whole blood. The user delivers a sample (e.g., a wholeblood sample) into a reaction chamber within the sensor, and the samplecan react with a reagent and electrodes positioned therein. The metercreates an electrical potential across the electrodes and collects data(e.g., time and current data). Based on the collected data the meter canprovide the user with information about an analyte within the sample(e.g., glucose concentration). FIG. 11D illustrates sensor 20 ready toreceive a sample.

Sensor 20 is generally intended for a single use and can be disposedafter analysis. For example, as shown in FIGS. 12A and 12B, aftercompletion of the test, the user can eject the spent sensor. In oneembodiment, sensor 20 is ejected from meter 49 by depressing and/oradvancing an ejection button 66. The testing procedure can be repeated,as desired, by feeding another sensor to meter 49 from sensor dispenser10.

The sensor used with sensor dispenser 10 can, in one embodiment, be anelectrochemical sensor having spaced apart electrodes that define areaction chamber. The sensor can further include electrical contacts,positioned on the surface of the sensor, which are in electrical contactwith the electrodes. These contacts allow a meter to electricallycommunicate with the electrodes positioned within the reaction chamber.FIGS. 3 and 4 illustrates one exemplary embodiment of a generally “V”shaped sensor that can be used with dispenser 10 and that includes alongitudinal reaction chamber 80 with laterally spaced electricalcontacts 82. In one aspect, reaction chamber 80 is positioned toward adistal end of the sensor and electrical contacts 82 are positionedtoward a proximal end of the sensor. The sensor can be dispensedproximal end first so that the meter receives the electrical contacts.

Sensor 20 can also include features that assist with dispensing. Forexample, sensor 20 illustrated in FIGS. 3 and 4 including a open region26 that can receive at least a portion of sensor dispenser 10. Asdescribed above, dispenser 10 and meter 49 can mate with surfacefeatures, such as open region 26, for holding and/or dispensing thesensor. One skilled in the art will appreciate that sensor 20 caninclude a variety of other features for mating with dispenser 10, suchas, for example, notches in the side of the sensor, apertures throughthe sensor, recesses or protrusions on the sensor, and combinationsthereof.

Sensor 20, in one embodiment, is part of an array of connected sensors(20 a, 20 b, 20 c, etc.). The sensors can be folded into aspace-efficient configuration for storage in sensor dispenser 10. In oneaspect, an array of fan folded sensors are positioned within dispenser10 and individually dispensed. The connection 32 between sensors allowsthe sensors to be stored in a folded configuration and then pivoted intoa planer configuration for dispensing. Once the meter mates with thesensor during the dispensing process, the connection can be broken(e.g., torn) to allow the sensor to be dispensed.

One skilled in the art will appreciate that sensor 20 can include thevariety of electrochemical sensors capable of being dispensed from adispenser. Exemplary sensors are described in a United States patentapplication entitled “Method and Apparatus for Electrochemical Analysis”filed on the same date as this application, and incorporated herein byreference in its entirety.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. An electrochemical sensor dispenser device,comprising: an elongate body having a proximal and distal end, theelongate body further including a proximally positioned dispensingsurface with an opening for dispensing an electrochemical sensor, theproximal end of the elongate body being configured for releasable axialengagement with a distal end of a test meter; a distally positionedchamber adapted for the storage of a series of electrochemical sensors;a sensor feeder mechanism disposed at the proximal end of said sensordispenser device, the feeder mechanism including an elongate memberhaving a first end and second end, the second end being adapted to movebetween a sensor engaging position and a sensor feeding position, theelongate member biased in the sensor engaging position prior toengagement with the test meter; and a mechanism enabling releasableengagement between the proximal end of the sensor dispenser device andthe distal end of a test meter for engaging and receiving a sensor fromthe dispenser device and in which the mechanism enabling releasableengagement is configured to automatically cause the elongate member tobe moved from the sensor engaging position to the sensor feedingposition when the proximal end of the dispensing device is engaged witha test meter.
 2. The device of claim 1, wherein the elongate member ofthe feeder mechanism is pivotally secured to the elongate body at thefirst end.
 3. The device of claim 1, wherein the elongate member of thefeeder mechanism is fixedly secured to the first body at the first endand is flexible.
 4. The device of claim 1, wherein the second end of theelongate member of the feeder mechanism is adapted to mate with asensor.
 5. The device of claim 4, wherein the second end of the elongatemember of the feeder mechanism has a shape that is complementary to anopen region on a sensor.
 6. The device of claim 1, further comprisingstops positioned proximate to the opening and adapted to resist movementof a sensor in a distal direction.
 7. The device of claim 1, wherein thebody includes alignment features to facilitate alignment of the devicewith a meter, separately engaged with the dispenser device.
 8. Thedevice of claim 7, wherein a portion of the proximally positioneddispensing surface extends beyond the sensor feeding mechanism toprovide an alignment surface.
 9. The device of claim 1, wherein the bodyincludes a window for visually inspecting the storage chamber.
 10. Thedevice of claim 1, wherein the body provides a generally air-tightenclosure of the storage chamber.
 11. The device of claim 1, furthercomprising a resealable opening at the proximal end.
 12. The device ofclaim 11, wherein opening the resealable opening provides access to theproximally positioned dispensing surface.
 13. The device of claim 1,wherein a series of connected sensors are positioned within the storagechamber.
 14. The device of claim 13, wherein at least a portion of thesensors are stored in the sensor storage area in a folded configuration.15. The device of claim 13, wherein the storage chamber includes guidefeatures adapted to restrain a stack of folded sensors.
 16. A system fordelivering an electrochemical sensor to a meter, comprising: a sensordispensing device having an elongate body including a sensor storagearea and a sensor dispensing mechanism disposed therein, the sensordispensing mechanism including an elongate member being adapted to movebetween a sensor dispensing position and a sensor engaging position; anda meter adapted to receive a sensor from said sensor dispensingmechanism, the meter having a distal end releasably engageable with aproximal end of the sensor dispensing device and including a surfaceadapted to engage the sensor dispensing mechanism and automatically movethe elongate member from the sensor dispensing position to the sensorengaging position upon axial engagement between the proximal end of thedispensing device and the distal end of the meter, the meter furtherincluding a sensor mating mechanism that can mate with a sensor moved tothe sensor dispensing position based on axial engagement of the metertherewith.
 17. The system of claim 16, wherein the sensor matingmechanism is adapted to lock a dispensed sensor in the meter.
 18. Thesystem of claim 16, further including a series of connected sensors inthe sensor storage area.
 19. The system of claim 17, wherein at least aportion of the sensors are stored in the sensor storage area in a foldedconfiguration.
 20. The system of claim 17, wherein the sensors each havea longitudinal reaction chamber and laterally spaced electrical contactareas.
 21. The system of claim 20, wherein the meter includes laterallyspaced electrical contactors adapted to electrically communicate withthe laterally spaced contact areas on the sensor.
 22. The system ofclaim 16, wherein the sensor dispenser includes a dispensing surfacethat is complementary to a surface on the releasably attachable meter.23. The system of claim 16, wherein the sensor dispenser includesalignment features that are complementary to a surface on the meter. 24.An electrochemical sensor dispenser device, comprising: an elongatecylindrical body having a distal end and a proximal end, the proximalend being configured for axially engaging the distal end of a testmeter; a distal sensor storage chamber retaining at least oneelectrochemical sensor, the at least one sensor including a longitudinalreaction chamber, two electrical contact areas, and a sensor dispensermating area; and a proximal sensor feeder mechanism adapted to mate witha sensor retained in said distal storage chamber, the feeder mechanismincluding an elongate member having a first end and second end, thesecond end of the elongate member being adapted to pivot between asensor engaging position and a sensor feeding position automaticallyupon engagement of the proximal end of the device with the distal end ofa test meter, the elongate member being initially biased in the sensorengaging position.
 25. The device of claim 24, wherein the second end ofthe elongate member has a shape that is complementary to the sensordispensing mating area on the sensor.